Engaging Stakeholders

In developing the proposed code of practice, the WHO should engage all major stakeholders; the inclusion of scientific experts and civil society groups is essential. The WHO Essential Medicines division can bring great technical depth to the discussion, especially the public health aspects of the problem. Because the problem has legal dimensions, it will also be crucial to include experts in law enforcement, criminal justice, and customs. In order to assure the proper range of expertise in the drafting of the proposed code of practice, the committee recommends that the WHO work with the UNODC and the WCO.

The UNODC helps member states fight organized crime, trafficking, corruption, and terrorism (UNODC, 2012a). Its previous work has described the trade in illegitimate medicines as the business of terrorist organizations and criminal cartels (UNODC, 2009, 2011, 2012b). The agency's 2012–2015 strategy emphasizes that responding to transnational, organized crime is a priority, and it highlights their work against new kinds of drug trafficking (UN, 2012). Contributing to the law enforcement and criminal justice sections of an international code on falsified and substandard medicines would draw on the agency's strengths and complement the goals set out in its 3-year strategy.

The WCO, the only international organization dedicated to policing flows of goods into and out of countries, is the other stakeholder organization that should contribute to the proposed code. The WCO works on supply chain security and on the harmonization of simplified customs procedures (WCO, 2012a). National customs offices are under pressure to facilitate international trade and to monitor the safety of products entering the country; they have a unique understanding of the circumstances through which illegitimate medicines enter commerce. The inclusion of the WCO in the development of an international code on falsified and substandard drugs could help ensure the code's validity to stakeholders in customs.

The committee recognizes that some stakeholders might object to the inclusion of the WCO in this process, given the organization's professed commitment to protecting intellectual property rights (WCO, 2012b). Monitoring the trade in illegitimate medicines and enforcing laws against them depend on customs bureaus, however. Failing to include them in the development of the code would risk its being unacceptable or impractical for customs officers, one of the main groups that would need to adhere to it. While some stakeholders might not approve of the WCO, the committee sees no value in excluding them from the discussion.

Global governance for health increasingly requires health organizations such as the WHO to work with other international agencies. There is precedent for the WHO's forming partnerships in the development of a code of practice. The WHO and Unicef collaborated on the International Code of Marketing of Breast-Milk Substitutes, and, since its release in 1981, 84 countries have enacted legislation implementing all or many of its provisions (Unicef, 2012; WHO, 1981). Unicef continues to work with legislators and lawyers to implement maternity protection laws in more countries (Unicef, 2012). Given the clear relationship between maternal and child health and Unicef's mission, it was only appropriate for the WHO to engage this organization. Similarly, a partnership with the UNODC and WCO would benefit the development and implementation of the proposed code of practice.

Recommendation 7-1: The World Health Assembly, in partnership with the United Nations Office on Drugs and Crime and the World Customs Organization, and in consultation with major stakeholders, should institute an inclusive, transparent process for developing a code of practice on the global problem of falsified and substandard medicines. The code should include guidelines on surveillance, regulation, and law enforcement, empowering states and the international community to prevent and respond to drug quality problems.

International Surveillance

As Chapter 3 explains, surveillance for substandard and falsified drugs is uncoordinated, largely voluntary, and highly variable. The modern drug supply chain involves many countries; therefore, drug surveillance should be a coordinated, global effort. International surveillance is necessary to define the magnitude of the problem and to identify priority areas for action.

The sections of the code that discuss surveillance should give guidance on how to set up routine drug quality surveillance and how to make strategic choices about which drugs to monitor in the most vulnerable regions. Once routine surveillance systems are running, data gleaned from them will inform some of these choices in an iterative process. It may be necessary to use active surveillance methods for some high-risk drugs and passive surveillance for others. The code might also recommend how to choose and manage key sentinel surveillance sites. The guidelines should also explain how to tie monitoring for falsified and substandard drugs to routine pharmacovigilance and how to link surveillance with response.

Drug surveillance also requires laboratories for quality testing. There are not sufficient drug-quality laboratories in most low- and middle-income countries to support the regulatory agencies' routine needs (IOM, 2012). And, as Chapter 6 explains, these assays are expensive; running even minimal tests could quickly bankrupt a small county's annual drug testing budget. The code should suggest ways to accommodate the added burden that surveillance will place on drug quality laboratories. There may be room for universities to take on more testing or for donors to fund dedicated, regional drug surveillance laboratories. The use of minilabs and hand-held detection technologies could also alleviate the added strain surveillance testing will place on drug quality laboratories.

Building surveillance also requires building a workforce dedicated to data analysis and the prompt dissemination of public alerts when necessary. Therefore, using surveillance data effectively requires a strong medicines regulatory system. Guidelines on surveillance for falsified and substandard drugs will depend on commensurate guidelines for the regulation of medicines.

Medicines Regulation

The proposed code of practice should give guidelines on the quality, safety, and efficacy of medicines that all countries can work toward. The code could suggest national minimum standards for licensing of importers, distributors, and wholesalers and guidelines on retail and dispensing of medicines. The WHO has already collected most of this information; the Medicines Regulatory Package will be a useful reference on how to organize regulatory authorities and monitor their performance (WHO, 2011).

The code should direct countries to enact comprehensive medicines legislation that provides for all the drug regulatory functions, including the licensing of manufacturers and distributors, the issuing of market authorization, the inspection and surveillance of the drug distribution chain, and the monitoring of medicines on the market (Rägo and Santoso, 2008).

The code should also give guidance on harmonization and mutual recognition. Having consistent requirements eases the regulatory burden on industry. Especially in small countries, harmonization allows regulators to make efficient use of their limited labor. The code might recommend opportunities for regulatory agencies in small countries to base their decisions on internationally accepted criteria. The regulatory agencies of Canada, New Zealand, Singapore, and Switzerland, for example, make more efficient use of their staff by accepting new chemical entity data from larger regulatory agencies (ICDRA, 2010; Jessamine, 2010).

The code might support the work the Pharmaceutical Inspection Co-operation Scheme has begun. The Pharmaceutical Inspection Convention and the Pharmaceutical Co-operation Scheme, known jointly as PIC/S, work to advance mutual confidence, training, and information exchange among 43 participating regulatory agencies (PIC/S, 2012b, 2013). PIC/S trains inspectors from around the world in pharmaceutical inspections; its trainings and publications promote harmonized understanding of good distribution and manufacturing practices (PIC/S, 2012c,d).

Efficient staffing of the regulatory authority depends on sustainable financing. The code could suggest methods for governments to ensure sustainable financing for their regulatory authorities. Most regulatory authorities run off public money or market authorization fees; many face an additional dilemma in soliciting user fees from the pharmaceutical industry (Abdul-Rahman, 1996). The code might address this problem and give guidelines on an appropriate financial relationship between the pharmaceutical industry and the drugs regulatory authority. A frank public discussion of this question might have an added benefit of encouraging investment in regulatory systems in developing countries. This includes investing in the training and credentialing of the professional workforce needed to run a regulatory system.

The code of practice could also lead to the development of accepted good regulatory practices, and tools regulators can use to benchmark their performance. The WHO is the ideal organization to lead the development of good regulatory practices because of its technical depth and experience in medicines regulation. The WHO has convening power to bring regulatory agencies together; its International Conference of Drug Regulatory Authorities brings regulators together to discuss common challenges and opportunities for collaboration (WHO, 2012a). The development of good regulatory practices could also draw on the work that the International Conference on Harmonisation and the forum for Asia-Pacific Economic Cooperation have done to the same end (Lourenco, 2008; Uyama, 2011).

Law Enforcement

Guidelines for surveillance and drug regulation will be central to a code of practice on substandard and falsified drugs. This report makes clear, however, that the problem cannot be solved without input from law enforcement, a broad category that includes disparate agencies with limited budgets and competing priorities.

The nature of pharmaceutical crimes and the constraints on law enforcement agencies pose challenges to prosecuting and punishing offenders. The illegitimate drug business is a global industry that mirrors legitimate business in many ways: it sources materials from around the world and bases manufacturing in countries with the cheapest labor and most favorable regulatory regimes. Criminals and unscrupulous manufacturers use the internet to identify suppliers and customers. They may also sell drugs over the internet, on the black market, or even through legitimate distribution channels. Thorough investigation and successful prosecution of those responsible is difficult and expensive because of clandestine manufacturing and distribution networks.

Pharmaceutical crime covers a spectrum of low-risk, high-reward offenses. Many countries have not enacted laws making these acts crimes or set out terms for international cooperation on investigations (Attaran et al., 2011). The code of practice on falsified and substandard medicines could give guidelines on how to investigate and punish the illegitimate medicines trade, as well as standard minimum punishments for different crimes. The code could also establish common definitions for different criminal acts such as the manufacture of an illegitimate drug, the unauthorized reuse of packaging, tampering with any documents or receipts necessary to recreate the chain of custody, and knowingly selling or distributing an illegitimate product.

A code of practice would build momentum for international cooperation on the investigation of pharmaceutical crimes. The national police agencies' authority stops at the border. Investigating transnational crimes sometimes requires mutual legal assistance treaties (Attaran et al., 2011; Palmer, 2012). Pharmaceutical crimes are particularly time-consuming and expensive to investigate. They put novel demands on the detectives and prosecutors who are expected to work on homicides and other violent crimes. The code of practice could suggest guidelines for police agencies on how to balance priorities. It could also give political cover to police agencies looking to direct more staff time to investigating crimes against the drug supply. The code would also establish guidelines for both choosing the venue to prosecute and the terms for extradition.

Chapter 4 describes how police and customs officers may channel their work against falsified drugs in brief, intense campaigns and not in sustained, coordinated action. The law enforcement guidelines in the proposed code of practice could explain how to integrate action against falsified drugs into daily police work. They would also allow police and prosecutors to make these crimes a priority.

At a minimum, the code should establish definitions for different crimes involving the medicine supply, establish minimum penalties for these crimes, recommend protocols for international cooperation on investigations and extradition, and clarify the role of customs and border police in investigating medicines trafficking. These actions could go a long way in increasing awareness of the gravity of pharmaceutical crime.

Compliance by States and Stakeholders

A code of practice is a voluntary agreement. Countries have no formal, legal obligation to conform. A code of practice can do much to raise awareness and promote harmonized actions among countries. Some recent commentary has suggested that the WHO should exercise more leadership on global health problems (Sridhar and Gostin, 2011). The organization is uniquely poised to convene stakeholders and issue a soft law for addressing this problem. An open and transparent convening process will lay the groundwork for future compliance with the code.

The WHO can also give incentives for compliance and encourage cooperation among nations. Countries that adopt the code should be able to report on their progress and share strategies for overcoming obstacles. The WHO Director-General could then report to the WHA on implementation and potential barriers to compliance. Nongovernmental organizations could also have a useful role in monitoring compliance with the code, perhaps issuing reports on which countries and stakeholder groups make good on their promises (Gostin, 2013).

One likely barrier to action is limited capacity for drug regulation, law enforcement, and surveillance in low- and middle-income countries. The code might suggest incentives, such as funding and technical assistance for implementation, as well guidance on how law enforcement agencies can work together across jurisdictions.

Costs are another important barrier to widespread adaption of the code. The PIC/S funds its activities through membership fees (PIC/S, 2012a). Attendance at conferences and trainings is extra (PIC/S, 2012a). The expense can be a barrier for regulators from poor countries. Furthermore, tracking countries' progress to meeting the code and planning member state activities will take staff time and administrative effort. It may be necessary to establish a WHO secretariat dedicated to the code of practice on falsified and substandard drugs. In this case, the WHA should direct the necessary funds to WHO for a formal secretariat to organize and administer related activities.

Substandard and falsified drugs are a global problem. It is difficult to accurately measure the burden of the problem, but illegitimate medicines appear in all countries, threatening health and undermining confidence in the medical system. The proposed code of practice will encourage coordinated international monitoring of medicine quality, strong regulatory systems, and the appropriate investigation and punishment of crimes against the drug supply. Prominent international action to protect the drug supply will advance public health around the world.